510(k) K880291 ยท LCA Radioimmunoassay, Theophylline
THEOPHYLLINE TEST KIT REF. #A874799
| Applicant | Photec Diagnostics, Inc., Little Falls NJ, US |
| Decision | Substantially Equivalent, Mar 24, 1988 |
| Received | Jan 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880291
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.